Contact information
Type
Scientific
Contact name
Mr Pilane Liyanage Ariyananda
ORCID ID
Contact details
SACTRC
Department of Medicine
University of Peradeniya
Peradeniya
20000
Sri Lanka
+94 (0)81 238 4556
ariyananda@sltnet.lk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
071669
Study information
Scientific title
A randomised controlled trial of high-dose immunosuppression in paraquat poisoning
Acronym
Study hypothesis
To assess whether intravenous cyclophosphamide and methylprednisolone, followed by dexamethasone, as supplementary therapy to a single dose of fullers earth or activated charcoal, prevents death from paraquat-induced lung fibrosis.
Please note that as of 15/01/2009 this record was updated to include an extended anticipated end date of 30/12/2010. The initial anticipated end date of this trial was 30/12/2008.
Ethics approval(s)
The Ethics Committee of the Faculty of Medicine, University of Ruhana gave approval on the 18th April 2006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Condition
Paraquat poisoning
Intervention
Two days of cyclophosphamide 750 mg (if weight is less than 50 kg) or one gram (if weight is more than 50 kg), and three days of methylprednisolone one gram both by intravenous infusion over one hour. Steroids in the form of oral dexamethasone (8 mg three times daily) will be continued for the next two weeks. Patients will receive mesna 400 mg intravenous at start of therapy and four and eight hours later to reduce risk of haemorrhagic cystitis.
Control patients will receive saline placebo infusion and placebo capsules.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Cyclophosphamide, methylprednisone, dexamethasone, fuller's earth or activated charcoal
Primary outcome measure
All-cause mortality in hospital
Secondary outcome measures
1. All-cause mortality at three months post-ingestion
2. Lung function in survivors at three months
Overall study start date
30/08/2006
Overall study end date
30/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with a history of acute paraquat poisoning
2. Presenting within 24 hours of paraquat ingestion with evidence of paraquat intoxication by urinary dithionite test
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
600 (300 active, 300 placebo)
Total final enrolment
299
Participant exclusion criteria
1. Under 14 years
2. Pregnant
3. Systolic blood pressure of less than 70 mmHg, unresponsive to one litre fluid challenge, Glasgow Coma Score (GCS) less than 8/15, or cyanosis
4. Already received cyclophosphamide or methylprednisolone for this episode of poisoning
5. Allergic to cyclophosphamide, methylprednisolone, dexamethasone or mesna
6. Unable to give consent, or not accompanied by a relative, where the hospital consultant prefers that consent be obtained from a relative rather than the consultant looking after the patient
7. Present more than 24 hours after paraquat ingestion
Recruitment start date
30/08/2006
Recruitment end date
30/12/2010
Locations
Countries of recruitment
Sri Lanka
Study participating centre
SACTRC
Peradeniya
20000
Sri Lanka
Sponsor information
Organisation
South Asian Clinical Toxicology Research Collaboration (SACTRC) (Sri Lanka)
Sponsor details
Department of Medicine
University of Peradeniya
Perideniya
20000
Sri Lanka
+94 (0)81 238 4556
adawson@sactrc.org
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Industry
Funder name
Syngenta Crop Protection AG (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 071669)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2018 | 01/07/2021 | Yes | No |